Obesity and Other HyperalimentationNCT03007368
Digestion of Foods Consumed in Africa
A study testing Rice, Potato and Pasta in people with Obesity and Other Hyperalimentation, run by Purdue University.
Trial summary
As populations become urbanized in Africa, the change to a more Westernized diet has been associated with rise in obesity and related metabolic syndrome diseases. The current study shows that in the West African Sahel, these replacement starchy staple foods have fast gastric emptying compared to traditional sorghum… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity and Other Hyperalimentation
- What is being tested?
- Rice, Potato and Pasta
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal body mass index (18 kg/m2 ≤ BMI ≤ 25 kg/m2)
Who cannot join
- Under any medication
- History of any gastrointestinal disease or surgery
- Diabetes
- Smoker
About this study
Official title: Assessment of Gastric Emptying and Fullness of Different Types of Foods in Mali
As populations become urbanized in Africa, the change to a more Westernized diet has been associated with rise in obesity and related metabolic syndrome diseases. The current study shows that in the West African Sahel, these replacement starchy staple foods have fast gastric emptying compared to traditional sorghum and millet foods; and implies that the latter could be beneficial in lowering glycemic response, providing energy from a meal over a longer time, and providing a satiety effect. Knowledge of this attribute of sorghum and millet foods could be useful to improve their image in West African cities to increase their consumption and to improve markets for local smallholder farmers.
Read the detailed description
As suggested by anecdotal evidence that traditional Malian sorghum and millet foods are filling and provide sustained energy, we hypothesized that gastric emptying rates of sorghum and millet foods are slow, particularly compared to non-traditional starchy foods (white rice, potato, wheat pasta) that are now commonly consumed in urban areas of the West African Sahel. A broader purpose for the study was to understand whether sorghum and millet foods have positive health attributes that can be promoted in urban areas to provide better markets for local farmers.
Two human trials of similar design were conducted approximately one year apart. The carbon 13 (13C)-labelled octanoic acid breath test method was used to measure gastric emptying rate, and subjective pre-test and satiety response questionnaires were used. In the first study, 14 healthy volunteers in Bamako, Mali participated in a crossover design to test eight starchy foods for gastric emptying rate and satiety feelings. The second study with six volunteers was done to correct for endogenous 13C differences in the starch component of the foods.
- Conditions
- Obesity and Other Hyperalimentation
- Being tested
- Rice, Potato, Pasta, Sorghum thick porridge, Millet thick porridge
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiceOther
Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
PotatoOther
Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response .
PastaOther
Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
Sorghum thick porridgeOther
Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
Millet thick porridgeOther
Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
Millet couscousOther
Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
Millet thin porridgeOther
Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
Millet thin monikuru porridgeOther
Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
| Study group | Role | What they receive |
|---|---|---|
| Rice | Experimental | Cooked white rice and tomato-based sauce Receives: Other: Rice |
| Potato | Experimental | Cooked white peeled potato and tomato-based sauce Receives: Other: Potato |
| Pasta | Experimental | Cooked macaroni product and tomato-based sauce Receives: Other: Pasta |
| Sorghum thick porridge | Experimental | Sorghum thick porridge and tomato-based sauce Receives: Other: Sorghum thick porridge |
| Millet thick porridge | Experimental | Millet thick porridge and tomato-based sauce Receives: Other: Millet thick porridge |
| Millet couscous | Experimental | Cooked millet couscous and tomato-based sauce Receives: Other: Millet couscous |
| Millet thin porridge | Experimental | Millet thin porridge Receives: Other: Millet thin porridge |
| Millet thin monikuru porridge | Experimental | Millet thin porridge containing cooked millet granules (monikuru) Receives: Other: Millet thin monikuru porridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying
Breath test was performed using 13C-octanoic acid mixed into test meals
Measured: acute study, 4 hours after consumption of test food
Secondary outcomes (1)
Appetitive response
Fullness and hunger questionnaire was given at various time points after consumption of test foods
Measured: acute study, 4 hours after consumption of test food
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startMar 2012
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obesity and Other HyperalimentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine
- Responsible party
- Principal investigator, Bruce R. Hamaker, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007368
- Sponsor's protocol ID
- 1104010761
- Status last verified
- Dec 2016
- First submitted
- 1 Nov 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Not shared
Publications
Ghoos YF, Maes BD, Geypens BJ, Mys G, Hiele MI, Rutgeerts PJ, Vantrappen G. Measurement of gastric emptying rate of solids by means of a carbon-labeled octanoic acid breath test. Gastroenterology. 1993 Jun;104(6):1640-7. doi: 10.1016/0016-5085(93)90640-x.
PubMed 8500721Choi MG, Camilleri M, Burton DD, Zinsmeister AR, Forstrom LA, Nair KS. [13C]octanoic acid breath test for gastric emptying of solids: accuracy, reproducibility, and comparison with scintigraphy. Gastroenterology. 1997 Apr;112(4):1155-62. doi: 10.1016/s0016-5085(97)70126-4.
PubMed 9097998Clegg ME, Shafat A. Procedures in the 13C octanoic acid breath test for measurement of gastric emptying: analysis using Bland-Altman methods. Scand J Gastroenterol. 2010 Aug;45(7-8):852-61. doi: 10.3109/00365521.2010.483740.
PubMed 20443742Schoeller DA, Klein PD, Watkins JB, Heim T, MacLean WC Jr. 13C abundances of nutrients and the effect of variations in 13C isotopic abundances of test meals formulated for 13CO2 breath tests. Am J Clin Nutr. 1980 Nov;33(11):2375-85. doi: 10.1093/ajcn/33.11.2375.
PubMed 6776794
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Gastric Emptying and Fullness of Different Types of Foods in Mali
- ClinicalTrials.gov ID
- NCT03007368
- Acronym / sponsor ID
- 1104010761
- Conditions
- Obesity and Other Hyperalimentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Baylor College of Medicine
- Study start
- Mar 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As populations become urbanized in Africa, the change to a more Westernized diet has been associated with rise in obesity and related metabolic syndrome diseases. The current study shows that in the West African Sahel, these replacement starchy staple foods have fast gastric emptying compared to traditional sorghum and millet foods; and implies that the latter could be beneficial in lowering glycemic response, providing energy from a meal over a longer time, and providing a satiety effect. Knowledge of this attribute of sorghum and millet foods could be useful to improve their image in West African cities to increase their consumption and to improve markets for local smallholder farmers.
Detailed description
As suggested by anecdotal evidence that traditional Malian sorghum and millet foods are filling and provide sustained energy, we hypothesized that gastric emptying rates of sorghum and millet foods are slow, particularly compared to non-traditional starchy foods (white rice, potato, wheat pasta) that are now commonly consumed in urban areas of the West African Sahel. A broader purpose for the study was to understand whether sorghum and millet foods have positive health attributes that can be promoted in urban areas to provide better markets for local farmers.
Two human trials of similar design were conducted approximately one year apart. The carbon 13 (13C)-labelled octanoic acid breath test method was used to measure gastric emptying rate, and subjective pre-test and satiety response questionnaires were used. In the first study, 14 healthy volunteers in Bamako, Mali participated in a crossover design to test eight starchy foods for gastric emptying rate and satiety feelings. The second study with six volunteers was done to correct for endogenous 13C differences in the starch component of the foods.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Rice | Experimental | Other: RiceCooked white rice and tomato-based sauce |
| Potato | Experimental | Other: PotatoCooked white peeled potato and tomato-based sauce |
| Pasta | Experimental | Other: PastaCooked macaroni product and tomato-based sauce |
| Sorghum thick porridge | Experimental | Other: Sorghum thick porridgeSorghum thick porridge and tomato-based sauce |
| Millet thick porridge | Experimental | Other: Millet thick porridgeMillet thick porridge and tomato-based sauce |
| Millet couscous | Experimental | Other: Millet couscousCooked millet couscous and tomato-based sauce |
| Millet thin porridge | Experimental | Other: Millet thin porridgeMillet thin porridge |
| Millet thin monikuru porridge | Experimental | Other: Millet thin monikuru porridgeMillet thin porridge containing cooked millet granules (monikuru) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal body mass index (18 kg/m2 ≤ BMI ≤ 25 kg/m2)
Key exclusion criteria (4 listed)
- Under any medication
- History of any gastrointestinal disease or surgery
- Diabetes
- Smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RiceDifferent modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response. | Other | Rice |
| PotatoDifferent modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response . | Other | Potato |
| PastaDifferent modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response. | Other | Pasta |
| Sorghum thick porridgeDifferent modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response. | Other | Sorghum thick porridge |
| Millet thick porridgeDifferent modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response. | Other | Millet thick porridge |
| Millet couscousDifferent modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response. | Other | Millet couscous |
| Millet thin porridgeDifferent modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response. | Other | Millet thin porridge |
| Millet thin monikuru porridgeDifferent modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response. | Other | Millet thin monikuru porridge |
Primary outcome
Gastric emptying
Time frame: acute study, 4 hours after consumption of test food
Breath test was performed using 13C-octanoic acid mixed into test meals
1 secondary outcome
Appetitive response
Time frame: acute study, 4 hours after consumption of test food
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
- Background: PubMed 8500721Ghoos YF, Maes BD, Geypens BJ, Mys G, Hiele MI, Rutgeerts PJ, Vantrappen G. Measurement of gastric emptying rate of solids by means of a carbon-labeled octanoic acid breath test. Gastroenterology. 1993 Jun;104(6):1640-7. doi: 10.1016/0016-5085(93)90640-x.
- Background: PubMed 9097998Choi MG, Camilleri M, Burton DD, Zinsmeister AR, Forstrom LA, Nair KS. [13C]octanoic acid breath test for gastric emptying of solids: accuracy, reproducibility, and comparison with scintigraphy. Gastroenterology. 1997 Apr;112(4):1155-62. doi: 10.1016/s0016-5085(97)70126-4.
- Background: PubMed 20443742Clegg ME, Shafat A. Procedures in the 13C octanoic acid breath test for measurement of gastric emptying: analysis using Bland-Altman methods. Scand J Gastroenterol. 2010 Aug;45(7-8):852-61. doi: 10.3109/00365521.2010.483740.
- Background: PubMed 6776794Schoeller DA, Klein PD, Watkins JB, Heim T, MacLean WC Jr. 13C abundances of nutrients and the effect of variations in 13C isotopic abundances of test meals formulated for 13CO2 breath tests. Am J Clin Nutr. 1980 Nov;33(11):2375-85. doi: 10.1093/ajcn/33.11.2375.
- Individual participant dataSharing planned: No. Not shared
Related trials for Obesity and Other Hyperalimentation
Active, not recruiting
Early Intervention in Cognitive Aging
Overweight, Obesity and Other Hyperalimentation (E65-E68)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rice, Potato and Pasta in people with Obesity and Other Hyperalimentation, run by Purdue University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric emptying (time frame: acute study, 4 hours after consumption of test food). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03007368, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2017.